Royal Philips NV is expanding its cardio footprint with the acquisition of Biotelemetry Inc., a manufacturer of remote medical technologies, for $2.8 billion, or $72 per share. The proposed deal, announced Friday, furthers Philips’ goal of providing integrated solutions across the care continuum, with Biotelemetry’s cardiac diagnostics and monitoring tools joining Philips’ line of hospital-based patient monitoring solutions. Philips expects the Biotelemetry business to contribute to sales growth and EBITA margin in 2021 and deliver double-digit growth and improve profit margins to more than 20% by 2025.

The U.S. FDA has granted IDE approval to the cardiac device startup Foldax Inc., to initiate clinical testing of its Tria mitral surgical heart valve. Patient enrollment is expected to begin in early 2021.

Genetesis Inc. received good news from the U.S. FDA in the form of a breakthrough device designation for Cardioflux for the diagnosis of myocardial ischemia and infarction in patients with symptoms suggestive of acute coronary syndrome. Mason, Ohio-based Genetesis provides biomagnetic imaging solutions with an eye toward ensuring safety. Its solution already has made an impression on clinicians.

PARIS – Cardiawave SAS has been granted authorization by the French National Agency for Medicines and Health Products Safety to extend its clinical trial in France and treat patients with calcific aortic stenosis (AS).

Edwards Lifesciences Corp. held its 2020 virtual investor conference Dec. 10, providing details on its 2021 financial outlook. The company is projecting global mid-teen sales growth totaling $4.9 billion to $5.3 billion and a return to double-digit sales growth in its transcatheter aortic valve replacement (TAVR) business. Earnings per share (EPS) guidance for the coming year is $2-2.20, below the consensus estimate of $2.21, due to investments in R&D and sales to fuel future growth.

Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc.

PARIS – Researchers at the Biomechanics and Bioengineering laboratory (BMBI), a joint venture between the Compiègne University of Technology in Oise, France, and the National Center for Scientific Research (CNRS), have designed a new implant intended for minimally invasive surgery for mitral valve repair. One of the BMBI teams has been working closely two cardiovascular surgeons from the University Hospital of Henri-Mondor to develop this new minimally invasive approach in the treatment of mitral valve regurgitation.

For the 795,000 Americans who suffer a stroke each year, time is brain. The U.S. FDA granted 510(k) clearance to a solution the developer says could cut time-to-treatment in stroke by an hour, preserving 3.6 years of healthy life. Nico.lab’s artificial intelligence-based CT scan analyzer, Strokeviewer LVO, uses an algorithm that enables faster triaging of stroke patients and enables physicians to see the location of occlusions in minutes.